Senior CSV Specialist – 11/21
KVK Tech is looking for Senior CSV Specialists to join our team in Newtown PA.
This position’s responsibilities will include, but not be limited to the following:
- Collaborate with system owner to develop URS, Design Qualifications, Functional Requirements, Unit test scripts, UAT scripts, Validation Plans and Protocols, Validation summary report and Traceability matrix
- Develop procedures specific to GxP Application SOP’s and provide SOP review for new systems.
- Perform Part 11 Assessments for new and existing computer systems
- Maintain GxP System log and update as necessary
- Execute the validation protocols, test scripts per Regulatory and GAMP guidance
- Perform Risk assessments for GxP systems
- Identify and implement opportunities for continuous improvement related to validation or other compliance practices/issues based on internal compliance issues, industry best practices as well as latest regulatory guidance’s and regulatory updates
- Identify, communicate and escalate project and compliance related issues associated with their projects to project Manager/Management
- Review and assess the impact of new Patches to validated GxP systems and validation of new patches
401(k) with matching
Health, Vision, Dental Insurance
Bonus Pay + Merit Increases
Paid Time Off
We are looking for applicants with:
- An Associates or Bachelors degree in related fields preferred
- One-year pharmaceutical industry experience preferred
- Applicable knowledge of DEA regulations
- Maintains a safe working environment
- Must be able to multi-task and work in a fast-paced environment
- Strong reading, writing, organization and communication skills are required
- Ability to resolve end user problems quickly
KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.
We encourage you to apply if you feel that you are a match! We look forward to hearing from you.